[Hiring] Manager, Commercial Quality Assurance @CG Oncology

Role Description

The Manager, Commercial Quality Assurance will manage quality assurance functions related to commercialization, clinical development, and regulatory compliance of products. This role is responsible for supporting the development, implementation, and maintenance of QA systems and activities, ensuring compliance with GMP standards. The Manager will lead audits, manage quality investigations, and collaborate with internal teams and external partners to resolve product quality issues. The role also includes oversight of documentation related to GMP activities. This role will support the Commercial Quality Assurance organization.

Location: Remote

Essential Functions

• QA Program Development: Support the development, improvement, and management of QA programs, policies, and procedures to ensure cGMP compliance.
• Vendor and Partner Management: Serve as the QA contact for specified vendors, contract facilities, or joint development collaborators. Ensure cGMP requirements are met through QA oversight, project team participation, and QA representation for batch manufacture oversight, validation activities, change management, and other GMP related activities. Support the process for Sponsor batch disposition.
• Document Review and Management: Perform QA review of manufacturing records, validation related records, batch records, and documents submitted to regulatory agencies.
• GMP Auditing and Inspections: Lead cGMP auditing of vendors. Support inspection readiness programs to ensure that the Sponsor and vendors have successful inspectional outcomes.
• Analytical Document Review: Review analytical documents related to release testing, stability testing, reference standards, and analytical method qualification/validation.
• Issue Resolution: Provide input on the vendor’s Quality System events, including change control, deviations, investigation, out-of-specifications, and CAPAs.
• Other: Perform other related duties as assigned or requested.

Qualifications

• BS/BA in a relevant scientific discipline.
• At least five (5) years of experience in Quality Systems and Quality Assurance processes, including development and documentation.
• A minimum of three (3) years demonstrating management of QA projects including directing and organizing personnel to complete critical timeline objectives.
• Experience with commercial drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
• Experience of managing contract manufacturers with direct operational QA oversight responsibilities.

Benefits

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION
• Well-Being Benefits: In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce.
• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS – In 2026 we will observe 14 holidays
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

Company Description

CG Oncology is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.